Wireless Medical Devices Fatih Mehmet Yurdal ITU WORKSHOP on

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ITU WORKSHOP on
SHORT RANGE DEVICES (SRDs)
AND ULTRA WIDE BAND (UWB)
(Geneva, 3 June 2014*)
Wireless
Medical Devices
Fatih Mehmet Yurdal
On behalf of ETSI TG30 Wireless Medical Devices
International
Telecommunication
2014
block of
Union
* in conjunction with the June
meetings of ITU-R Study Group 1
Wireless Technology in Medical Devices-1
- Incorporation of wireless communication technology in medical
devices has many benefits including increasing patient
mobility by eliminating wires that tether a patient to a
medical bed, providing health care professionals the ability
to remotely monitor the patient data regardless of the
location of the patient or physician (hospital, home etc.).
- Wireless monitoring permits patients to thrive outside
medical environments, reducing health care costs and
enabling physicians to obtain vital information on a real-time
basis without the need for office visits or hospital
admissions.
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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Wireless Technology in Medical Devices-2
- Remote monitoring can also help through home monitoring
of chronic diseases so that changes can be detected
earlier before more serious consequences occur.
- Wireless communication technology has been used for
more than 20 years by medical implant telemetry using
inductive coupling (less than 2 cms) operating in the 9-315
kHz band.
- Other frequency bands are designated for wireless
medical devices such as wireless medical telemetry
systems (WMTS), tele-health, assistive listening devices
(ALD) for hearing impaired, and the emerging medical
body area network systems (MBANS).
- Ultra-wideband technology is also envisioned as an
emerging technology in wireless healthcare.
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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Existing Operational Environment
- Wireless medical devices and networks operate in several
frequency bands and usually share the radio spectrum with
other wireless services on no-interference no-protection
basis under various national and international rules.
However, a few countries offer protection to specific
applications (e.g.; medical telemetry).
- Existing operational environment of the current wireless
medical devices, including available regulations and
standards, is presented in the following slides:
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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Medical Implant Communication System-1
- Medical Implant Communication System (MICS)
communicates data (excluding voice and video) from implants
(e.g. implantable defibrillator and cardiac pacemaker) inside
human body to an external device (controller, programmer)
for the purpose of programing the implantable devices and
monitoring patient’s data.
- ITU-R Recommendation RS.1346 provides for “Sharing
between the meteorological aids service and medical implant
communication systems (MICS) operating in the mobile
service in the frequency band 401-406 MHz”.
- MICS is permitted to operate at an e.i.r.p. level of -16
dBm (25 microwatts) or less in a reference bandwidth of
300 kHz in order to provide adequate protection to the
Meteorological Aids Systems.
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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Medical Implant Communication System-2
Following frequency bands are used for MICS:
 9–315 kHz used by all implantable medical devices e.g.
implantable pacemakers, defibrilators, neurostimulators etc.
 30–37.5 MHz for membrane implants
 401–406 MHz for Ultra Low Power Active Medical Implants
(ULP-AMI)
 2483.5–2500 MHz for Low Power Active Medical Implants
(LP-AMI)
It is very vital that the frequencies, regulations and standards
be globally harmonized for medical implant communications due to
the cross border mobile character of patients with implantable
medical device.
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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Medical Implant Communication System-3
- MICS operates globally in parts of the band 401-406 MHz
on a licence-exempt basis (Rec. ITU-R RS.1346). The core
band 402-405 MHz of MICS is designated to ULP-AMI in
more than 110 countries including Canada, USA, Europe,
Japan, China, India, Australia, NZ, several countries in Latin
America, Middle East and Africa.
- There is a need for international cooperation to harmonize
the protected status of ULP-AMI in the 401-406 MHz and
the expansion into the bands 401-402 MHz and 405-406
MHz. These bands are designated for ULP-AMI in Europe,
Canada, USA, Australia and New Zealand.
- International cooperation is also needed to harmonize the 9315 kHz band used by ULP-AMI legacy telemetry systems.
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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Wireless Medical Telemetry System-1
- Wireless Medical Telemetry System (WMTS) communicates
data (except voice and video) for remote monitoring of a
patient's health.
- A WMTS system consists of a set of sensors to measure
patients' vital signs and other body functions (e.g., pulse
and respiration rates) and devices to transmit the data via
a radio link to a remote receiver/location.
- These devices operate in various bands between 600 and
1432 MHz band in a number of countries at distances up to
several hundred feet.
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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Wireless Medical Telemetry System-2
- Europe has considered the bands 608-614 MHz, 1 3951400, and 1429-1432 MHz and decided not to use them
for WMTS because of their use by other services.
- The status of WMTS and its frequency bands are not
harmonized globally or regionally.
- Therefore, WMTS service status and the harmonized use
of WMTS frequency bands need to be addressed and
harmonised internationally if possible.
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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Assistive Listening Devices-1
- Assistive listening devices (ALD) are radio enabled hearing
aids devices.
- Hearing aids can be described as body worn therapeutic
medical devices used to provide improved medical
treatment of a patient.
- Hearing aids consists of basic “miniature audio amplifiers”
placed in or behind the ear(s) solely boosting the incoming
sounds.
- For public use it may be beneficial to have a standardized
wireless system, operating on globally harmonized tuning
range(s)
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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Assistive Listening Devices-2
- Following frequency bands are used for ALDs nationally,
regionally or internationally on a non-harmonised basis:








3-11 MHz (Not implemented in all regions)
72-76 MHz (Not implemented in all regions)
169 MHz band (Europe and Japan only)
173-175 MHz (some European countries and partly Korea)
174-216 MHz (Europe)
216-217 MHz (USA )
217-220 MHz (China)
863-865 MHz (Europe)
- It is very vital that the frequencies, regulations and
standards be globally harmonised for ALDs due to the
cross border mobile character of users
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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Medical Body Area Network System-1
- It is anticipated in the recent years that there is a need
for a network to replace wired cables used today between
patient’s body and sensors/equipment with wireless.
- Such a network could be created by Medical Body Area
Network System (MBANS) through attachment to the
patient of multiple, inexpensive, wireless sensors or network
nodes at different locations on or around a patient’s body to
take readings such as temperature, pulse, blood glucose
levels, blood pressure, respiratory function and other
physiological metrics.
- This information would be transmitted to a hub that is
either worn by the patient or located nearby. The hub could
be equipped to initially process the information and then
transmit the data to a central location.
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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Medical Body Area Network System-2
- Essentially, the MBAN system is a way to collect data from
multiple sensors, process the data and then send it through
a WMTS system or by wire to a monitoring station.
- Vital sign monitoring improves recognition and response to
changes in patient’s condition.
- MBANS enables immediate and seamless integration of
patient data into support systems.
- MBANS would not involve implanted devices.
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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Medical Body Area Network System-3
- Recently, 2483.5-2500 MHz band was designated for use by
MBANS in Europe, while 2360-2400 MHz was chosen in USA.
- The relevant European Standard for MBANS (EN 303 203) is
under approval process within ETSI.
- In the USA, 2360-2390 MHz band can only be accessed via
control message (electronic key) and appropriate coordination
between MBAN coordinator and AMT coordinator.
- 2390-2400 MHz can be used anywhere, no restrictions apply
- A mechanism is considered to ensure MBAN in 2360-2390
MHz only operate indoors, and cease operation in 2360-2390
MHz when device move outdoors automatically.
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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Ultra-wideband medical radar imaging-1
- Ultra-wideband (UWB) medical radar imaging system
consists of sensors that employ UWB technology to detect
the location and movement of internal organs and objects
inside the body of a human or an animal.
- UWB devices can be used for very high data rate
communications (>1 Gbps), which makes the technology
potentially useful for medical applications that involve
large file or database transfers.
- In addition, UWB devices are able to detect motion, and
therefore can be used to measure heart rate, respiration,
and patient body movement over a very short range (less
than 1m).
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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Ultra-wideband medical radar imaging-2
- Because UWB technology can transmit large amounts of
data, UWB imaging devices can be used to create
extremely sharp images of bones and internal organs.
-
UWB medical radar imaging devices are slowly entering
the marketplace. Several countries (US 2002, Singapore
2003, Australia 2004, New Zealand 2005, Hong Kong
2005, Japan 2005, Europe 2006, and South Korea 2006)
have adopted domestic UWB rules that permit medical
imaging devices in portions of the band 3.1-10.6 GHz.
- However, these rules are not harmonized worldwide.
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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Need for Harmonisation-1
- Demand on radio spectrum for use in current wireless
medical applications is on the increase. This demand is
driven by a rapid increase in the use of current medical
devices, advancements in wireless technologies, and the
need to improve quality, reliability and delivery of
healthcare.
- Wireless technologies are increasingly involved, in one way
or the other, in the treatment of most of the health
problems today or in the future. A schematic presentation
of the existing or planned medical devices is given in the
following slide:
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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Wireless Medical Device Proliferation
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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Need for Harmonisation-2
- Some wireless medical devices and systems are life-supporting
and life-saving applications which may require secure, highquality, and high reliability links whenever and wherever the
patient moves, including cross-border moves.
- The use of dedicated spectrum for some medical applications
need to be standardized and harmonized internationally.
- Harmonization will benefit the user, the wireless medical
industry, and regulators. It will also impact positively on costsaving, quality, reliability and delivery of healthcare.
- In addition, if international collaborations can lead to common
standards, it might be possible to negotiate mutual recognition
of approval processes between regulatory authorities without
undermining essential aspects of individual national legislations.
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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Need for Harmonisation-3
- In general, where SRDs operate in bands that are not
harmonized either on global or regional basis, risks to
radiocommunication services increase.
- Moreover, differences in spectrum access conditions and
technical rules increase the costs to consumers.
- Common frequency bands and technical rules, such as
recommended power levels and mitigation techniques,
should be developed in ITU-R Recommendations and
Reports as guidance for national administrations.
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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Need for Harmonisation-4
In summary;
Further studies may need to be undertaken in ITU-R to
determine whether global or regional harmonization is
feasible, given that there are a number of wireless medical
applications, such as those operating across national borders
that would benefit from worldwide harmonization.
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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THANK YOU FOR LISTENING
ITU Workshop on Short Range Devices (SRDs) and Ultra Wide Band (UWB), 3 June 2014, Geneva
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